HERPES TREATMENT

FDA Approves Supplemental New Drug Application For Antiviral Treatment Famvir(R)

July 31, 2006

Novartis Pharmaceuticals Corporation announced today the U.S. Food and Drug Administration (FDA) approved prescription Famvir(R) (famciclovir) tablets as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH), based on a supplemental new drug application (sNDA). Famvir significantly reduced the time to healing of non-aborted lesions, as well as time to resolution of studied symptoms in RGH patients with lesions by almost two days. The FDA also approved Famvir as a single-dose treatment for recurrent herpes labialis (cold sores) in immunocompetent patients.

“Famvir is the first and only antiviral approved to treat recurrent genital herpes in a single day,” said Gregory Geba, MD MPH, Vice President and Therapeutic Area Head of Respiratory, Dermatology and Infectious Diseases, Novartis Pharmaceuticals Corporation. “The new data demonstrates that Famvir can minimize a recurrent genital herpes outbreak, and stop symptoms such as pain and burning, in a median of less than a day. More importantly, Famvir can also stop an outbreak from occurring altogether in many patients.”

When an outbreak is triggered in the body, there is a narrow window of opportunity for treatment since the virus is replicating most actively in the first hours of an outbreak. Data shows that when patients were treated with the oral antiviral Famvir during this critical period of time, it shortened the duration of outbreaks and improved the time to resolution of symptoms. Millions of Americans live with the pain and discomfort associated with the outbreaks brought on by these conditions.

The new approved dosage of Famvir for RGH is 1,000 mg twice daily for one day. Therapy should be initiated within six hours of the first sign of prodromal symptoms, such as tingling, itching, burning or lesion appearance. Ninety-one percent of patients can identify their prodrome allowing them to initiate therapy in this narrow window of opportunity.

Similarly, the cold sore virus is most active during the first hours of an outbreak. Data shows that when a single 1,500 mg dose of Famvir therapy is initiated within one hour of the first sign of symptoms (tingling, itching or burning) of a cold sore, Famvir significantly reduced the time to healing by a median of almost two days, as well as the time to resolution of pain and tenderness by a median of one day.

“This is exciting news for the millions of people who live with these conditions,” said Dr. Geba. “Treating at the first sign of symptoms, when the virus is generally most active, significantly influences the management of outbreaks.”

About the Data

Recurrent Genital Herpes (RGH): Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-day Famvir (1,000 mg orally twice; n=163) with placebo (n=166) showed that when immunocompetent adult patients with RGH initiated therapy with Famvir at the first symptom/sign of an outbreak (within six hours), Famvir significantly reduced (P<0.001) the time to healing of non-aborted lesions by almost two days (median time, 4.3 vs. 6.1 days). Furthermore, the proportion of patients with aborted lesions was significantly larger (P=0.003) in the Famvir group as compared to placebo (23% vs. 13%). Famvir also significantly reduced (P<0.001) the duration of all studied symptoms consisting of burning, tingling, itching, pain, and tenderness in patients with lesions vs. placebo (median time, 3.3 vs. 5.4 days). Adverse events were of mild to moderate severity, and were similar in frequency and severity to those in the placebo group.

Cold Sores: Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-dose Famvir (1,500 mg orally once; n=152), or single-day Famvir (750 mg orally twice; n=152) with placebo (n=168) showed that when immunocompetent adult patients with cold sores initiated therapy with Famvir at the first symptom of an outbreak (within the first hour) but before the appearance of lesions, Famvir significantly reduced (P<0.001) the time to healing of primary vesicular lesions by almost two days (median time, 4.4 and 4.0 days vs. 6.2 days, respectively). There was no significant difference between treatments in the proportion of patients with aborted lesions. The study also showed that single dose Famvir (1500mg orally once; n=227) compared to placebo (n=254) also significantly reduced (P<0.001) the time to resolution of pain and tenderness in patients with lesions by one day (median time, 1.7 vs. 2.9 days, respectively). Adverse events were mild to moderate severity and were similar in frequency and severity to those in the placebo group.

About Genital Herpes

Genital herpes is one of the most common sexually transmitted diseases in the United States. Approximately one in five or about 50 million Americans are infected with genital herpes. Nearly 90 percent of people affected with genital herpes may not know they are infected. Anyone who is sexually active with an infected partner can get genital herpes; however, typically more women are diagnosed with genital herpes than men.

There is no cure for genital herpes. Oral antiviral medications such as Famvir are indicated to treat or suppress RGH. People with recurrent genital herpes can treat it suppressively, by taking medication every day, or episodically, by taking medication when each outbreak occurs. The majority of people who use prescription treatment for genital herpes manage their symptoms through episodic treatment.

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About Cold Sores

Cold sores, medically known as herpes labialis, are an infection of the mouth area with the herpes simplex virus. It is estimated that cold sores affect 66 percent of American adults — with most Americans being infected by the age of 20 years. Annually, approximately 100 million episodes of recurrent cold sores occur in the U.S. Oral antiviral medications can shorten the course of an outbreak and improve the time to resolution of symptoms (pain and tenderness) associated with cold sores. However, there is no cure for cold sores.

About Famvir

Famvir (famciclovir) tablets are indicated for the treatment or suppression of recurrent genital herpes in immunocompetent patients; the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients; the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients; and the treatment of acute herpes zoster (shingles).

The efficacy of Famvir has not been established for initial-episode genital herpes infection, ophthalmic zoster, disseminated zoster, or in immunocompromised patients with herpes zoster. The safety and efficacy of Famvir for suppressive therapy has not been established beyond one year.

There is no cure for genital herpes. There is no evidence that Famvir can stop the spread of herpes to others.

Famvir is Pregnancy Category B. Famvir is contraindicated in patients with known hypersensitivity to the product, its components, or Denavir(R) (penciclovir cream).

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world.

The foregoing release contains forward-looking statements that can be identified by terminology such as “committed to helping” or similar expressions, or by express or implied discussions regarding the approval of a new indication for Famvir by the FDA, or regarding the potential approval by regulatory authorities in other countries, or regarding potential future sales of Famvir. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Famvir to be materially different from any future results, performance or achievements expressed or implied by such statements. There can not be any guarantee that Famvir will reach any particular sales levels. In particular, management’s expectations regarding commercialization of Famvir could be affected by, among other things, additional analysis of Famvir clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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WTC: Surgeons Describe Face-Saving Transplant

July 28, 2006

Eight months after becoming the first person in the world to undergo a partial face transplant, the patient is doing well with excellent cosmetic and functional results, reported transplant team members.

Within a week of surgery the patient, subsequently identified as 38-year-old Isabel Dinoire, was able to eat and drink almost normally, said Emmanuel Morelon, M.D., of the Hôpital Edouard Herriot in Lyon, France. She had rapid improvement of speech, and by six months had return of normal heat and cold sensation at all points tested in the partial facial graft.

There were no surgical complications, although Dinoire did experience two episodes of rejection, which required heavy treatment with immunosuppressants, said Dr. Morelon, who presented follow-up data at the World Transplant Congress here on behalf of the French-Belgian team.

In the procedure performed last November in Amiens, France, Dinoire received a nose, chin and lips from a brain-dead donor to repair facial disfigurement she suffered after being mauled by her dog about seven months earlier.

Dinoire suffered amputation of the distal portion of her nose, both lips, chin, and adjacent parts of the cheeks. Because of the difficulties of reconstructing extensive soft tissue facial defects, and because of the poor cosmetic and functional results typically seen with autologous tissue grafts to the face, the surgeons decided to undertake the radical step of a partial face transplant, Dr. Morelon said.

Although full facial transplants are not currently approved in France, partial facial tissue transplants are acceptable when they are the only possible method for reconstructing an anatomical facial defect, said Laurent A. Lantieri, M.D., from the Hôpital Henri Mondor in Paris in an interview.

Dr. Lantieri, who was not involved in the study, is part of another surgical team studying the best methods for anatomical facial grafts. He had previously criticized Dinoire’s surgical team members because they did not first attempt an autologous tissue reconstruction as recommended by French ethical guidelines.

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The decision to attempt a partial facial transplant was based on the fact that the injury involved all soft tissues of the face, including the skeleton and teeth, with the largest defect in the right buccal and zygomatic areas.

Because conventional reconstructive surgery would have required a minimun of four operations to restore the missing tissues, and because of the likelihood of a poor functional and aesthetic outcome, the surgeons decided to attempt the challenging but feasible alternative of a face transplant in a single procedure.

The donor was a 46-year-old woman who was brain dead after suffering severe, irreversible cerebral ischemia.

The surgeons harvested the central and lower portions of the face, including the underlying vasculature and muscles. They performed vascularization of the grafts right and left facial arteries and veins following a cold ischemic time of four hours. The surgeons also performed mucosal repair of the oral and nasal vestibules, bilateral anastomoses of infraorbital and mental sensitive nerves, joining of mimic muscles with motor nerve suture on the mandibular branch of the left facial nerve, and skin closure.

They also implanted under one of her breasts a radial forearm flap from the donor to serve as a sentinel for rejection. That way, they could perform skin biopsies without compromising the integrity of the facial graft, Dr. Morelon explained.

The immunosuppressant regimen consisted of thymoglobulin, Prograf (tacrolimus), CellCept (mycophenolate mofetil), Imuran, and prednisone. The patient also received two infusions of donor bone-marrow cells, on days four and 11 after surgery, to help her immune system accept the new tissue.

Her follow-up care included routine tests, biopsies, physiotherapy, and psychological support.

While the initial postoperative course was unenventful, Dinoire suffered a first episode of a mild clinical rejection with erythema and edema along the suture line at day 18, confirmed by skin and mucosal biopsy. The reaction was not reversed by increased corticosteroids and topical Prograf at first, but it responded after three bolus infusions of Imuran and increased doses of Prograf and CellCept, Dr. Morelon said.

Dinoire had a second episode of rejection at six months, one month after having an infection with human herpes virus 1. Again, she responded to three boluses of prednisolone and to temporary increases in immunosuppressants. She also had a molluscum contagiosum infection caused by infection with poxvirus, at seven months.

Heat and cold sensitivity tests of the graft, which were all negative at two weeks, were mostly positive by four months, and completely positive by six months. The patient’s ability to sense light touch in the graft area showed a similar pattern of improvement.

Her passive and active lip occlusion abilities have also improved, and were nearly normal at eight months, and she is able to smile.

“I believe we have demonstrated that facial transplantation is a feasible procedure for severely disfigured patients,” Dr. Morelon concluded.

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5 QUESTIONS MEN & WOMEN DON’T ASK THEIR DOCTORS

July 24, 2006

Everyone has questions that go unasked and unanswered at the doctor’s office. Whether out of embarrassment or the underlying fear that something may be seriously wrong, men may try to avoid asking about unusual pains or irregular symptoms. From hernia testing to tender testicles, here are answers to 5 questions you may have wondered about.

Q. Why do I have to turn my head and cough during a hernia exam?
A. Notice that when you cough, the muscles in your abdomen tighten and flex. That increase in abdominal pressure can make a hernia pop out, making it easier for a doctor to detect. Though hernias usually present as a bulge, you could easily have a hernia and not know it. Another reason is to diagnose varicoceles, which are varicose veins of the testicles. With a good cough, the veins will protrude much like the veins in your neck do. Varicoceles are the most common cause of infertility in men. The doctor asks patients to turn their heads to avoid being coughed on all day.

Q. Is it true that you never really get rid of herpes?
A. There is not a cure for herpes nor is there a vaccine to prevent it yet.
The herpes simplex virus (HSV1 is oral herpes; HSV2 is genital) remains in nerve cells for life. When active, which can be several times a year, HSV travels along nerves to the skin, where sores become apparent. After a recurrence, the virus travels to the bottom of the spine and remains dormant there until the next outbreak.
But herpes is manageable. Controlling outbreaks is vital both for your comfort and for preventing contagion. Talk to a health-care professional about taking care of sores and the medications available to speed healing.

Q. Is it true that there is a male birth control pill?
A. No. There is no male birth control approved for use, and it’s unlikely one will be developed. The best options for men are wearing a condom, having a vasectomy, or abstinence.
Interestingly, testosterone-the hormone that gives men sex drive and erections-has contraceptive side effects. When it’s taken as a hormone supplement the testicles get the message that there’s already enough testosterone in the bloodstream, and sperm production is halted.
Long-term testosterone therapy will lead to zero sperm count. This is why steroids make men sterile.

Q. Can stress cause body odor?
A. Indirectly, stress can contribute to BO. But don’t blame it all on your boss, your bills or even your overactive sweat glands.
The body uses different sweat glands for stress than for physical exertion. Anxiety stimulates the glands in the armpits, in the groin and on the scalp, palms and feet. Unlike the salty sweat that covers our chest and back when we need to cool down, stress sweat is fatty-which makes it an especially fine meal for bacteria.
Perspiration is itself odorless. But when bacteria on skin and clothes begins breaking down fatty sweat, which stinks.
The solution? Minimize the bacteria on your body by showering regularly and wearing clean clothes. Use deodorant, which not only masks odor but makes the skin acidic and therefore less inhabitable to bacteria.
It’s not complicated. Perhaps your co-workers will even chip in for soap.

Q. What causes tenderness in the testicles, besides injury?
A. Any noticeable soreness or tenderness in the testes should be brought to the attention of a urologist immediately. It may very well be nothing, but here are some things that could be wrong:
Epididymitis is an infection of the epididymis, the long tube coiled up behind each testicle that acts as a veritable ‘swimming school for sperm’ - sperm enter relatively immobile and exit the other end doing a flutter kick. It’s the most common infection of the testicular area, and the usual suspect is the sexually transmitted disease chlamydia.
Testicular cancer typically presents as a lump on a testicle. Though usually painless, the area will sometimes be tender. TC is the most common but also one of the most treatable cancers in males ages 15 to 45.

Women everywhere dread going to the OBGYN. It’s not just the cold metal stirrups. Sometimes invasive medical procedures can make us anxious to get out of the office ASAP. Meanwhile, some of the questions we were dying to ask the doctor are forgotten. If you’ve ever worried about your low sex drive or wondered what you can do for mild PMS, now’s the time to get your questions answered.

Q. I don’t enjoy sex very much because I often experience discomfort. Is there anything a doctor can do for this?
A. Physical and emotional factors alike can contribute to painful intercourse, or dyspareunia. Certainly there are gynecological conditions that manifest as sexual discomfort, and most of them can be resolved with a physician’s guidance. It’s important to be evaluated.
Common conditions represented by superficial pain include yeast infections, dryness and vulvodynia (pain in the vulva). Vaginismus, a spasmodic tightening of the vaginal muscles, can have roots in a medical malady or be a psychological reaction to sex.

Q. I’m having trouble conceiving. What can my husband and I do before resorting to expensive treatments?
A. Healthy bodies allow you to have a baby, and healthy bodies produce healthy babies. It’s really not rocket science. Women and men alike can give fertility a strong head start by minding the following:
Avoid alcohol, Avoid coffee, Eat healthy, unprocessed foods, Reduce stress, Don’t smoke
Don’t use marijuana or other drugs, Take multivitamins, Have sex!
Many factors will come into play-age, body weight, medical history-but there are several avenues of treatment to pursue. Not all are expensive, and you might even get some assistance from your insurance carrier.

Q. Is there anything I can do about my terrible PMS?
I only have it a few days each month, but those days are wretched.
A. There are over 150 symptoms associated with premenstrual syndrome, from acne to swollen feet to wishing your spouse would get hit by a bus. But if you’re having extreme symptoms such as incapacitating pain, significant depression or cramps outside your normal cycle, consult a doctor to rule out more serious conditions. Although there’s no cure-all, the right diet and exercise can bring physical and emotional relief.
Dial back the caffeine, which can bring on mood swings as well as breast soreness, and avoid alcohol. Reduce your intake of salt, sugar, fatty foods and red meat. The evidence on herbal remedies like primrose oil and chaste tree berry is anecdotal; some women swear by them, some swear at them.

Q. My doctor doesn’t want to prescribe hormone replacement therapy, but my hot flashes and insomnia are destroying my daily life. What can I do to get some relief?
A. For women who do not get relief from lifestyle measures, a retreat from all therapy does not make sense. Quality-of-life studies indicate that women who do get relief are better off with the therapy. And for about 85 percent of women, this is going to be short-term treatment.
Hormone replacement therapy (or HRT) treats menopausal symptoms by replenishing estrogen and/or progesterone, which the body stops producing in menopause. Establish whether your doctor is drawing a hard line against the therapy or if your personal medical history puts you at higher risk.

Q. This is really embarrassing, but I suffer from constipation and gas a lot. Is that
a sign of something serious or should I just try to live with it?
A. The body is designed to work correctly; any malfunction signals a problem
worth investigating.
In the greatest number of cases, patients find complete relief with a modification of eating habits. Nonetheless, constipation and gas can signify digestive conditions such as ulcers, lactose intolerance and acid reflux. The concurrent presence of the two could imply an obstruction in the lower GI tract, which is sometimes caused by diseases of the colon. Or you could be pregnant.
Over-the-counter and home remedies can bring relief-active charcoal tablets, or antacids for gas; plenty of fiber and water for constipation-but prolonged self-medication can mask real problems or even create new ones

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Anti-HIV Therapy for Kids Prevents Opportunistic Infections

July 19, 2006

The modern era of anti-HIV treatment has dramatically reduced the rate of opportunistic infections among HIV-positive children and adolescents, according to researchers here.

For the most common infections, children and adolescents treated with highly active anti-retroviral therapy (HAART) have had significant declines compared with children before the HAART era began in 1996, found Philimon Gona, Ph.D., of the Harvard School of Public Health and Boston University here.

Because of advances in therapy, opportunistic and other infections are uncommon in HIV-positive children today, as well as being lower than in the pre-HAART era, Dr. Gona and colleagues reported in the July 19 issue of the Journal of the American Medical Association.

The researchers arrived at their conclusions by retrospectively studying the rate of 29 infections in 2,767 HIV-infected infants, children, and adolescents who were enrolled in the Pediatric AIDS Clinical Trials Group (PACTG) 219C from Jan. 1, 2001, to Dec. 31, 2004. PATCG 219C is a continuing prospective cohort study with the aim of studying the long-term consequences of HIV infection, treatment effects, and interactions of HIV disease and therapy in American infants, children, and adolescents.

For comparison rates, the researchers used a meta-analysis, published in 2000, of 3,331 HIV-infected children who had participated in PATCG clinical trials.

The main outcome measure was the first occurrence in a study participant of each of the 29 targeted infections.

During the study period, 553 first episodes of a specific infection occurred among 395 (or 14%) of the study participants. The four most common first-time infections which bacterial pneumonia, herpes zoster, dermatophyte infections, and oral candidiasis, with 123, 77, 57, and 52 cases respectively, the researchers said.

The incidence rates per 100 person-years were 2.15 for bacterial pneumonia, 1.11 for herpes zoster, 0.88 for dermatophyte infections, and 0.93 for oral candidiasis.

The incidence rates of first bacteremia, Pneumocystis jeroveci pneumonia, disseminated Mycobacterium avium complex, lymphoid interstitial pneumonitis, systemic fungal infection, cytomegalovirus retinitis, and tuberculosis were all less than 0.50 per 100 person-years, the researchers reported.

By contrast, the pre-HAART incidence rates were 11.1 cases per 100 person-years for bacterial pneumonia, 3.3 for bacteremia, 2.9 for herpes zoster, 1.8 for disseminated M. avium complex, 1.3 for P. jeroveci, 1.2 for oral candidiasis, 0.5 for cytomegalovirus retinitis, and 0.2 for tuberculosis.

With the exception of systemic fungal infection, all of the declines were statistically significant at P<0.001, Dr. Gona and colleagues reported. No such trend was seen for systemic fungal infection, probably because only eight cases were seen pre-HAART and six post-HAART.

“Clearly, antiretroviral medications work,” commented Joseph Harwell, M.D., of Brown Medical School in Providence, R.I., and Stephen Obaro, M.D., Ph.D., of the Children’s Hospital of Pittsburgh in an editorial. The study by Dr. Gona and colleagues shows that “antiretroviral therapy can reduce infectious complications even for common childhood illnesses, such as bacterial pneumonia and bacteremia.”

However, they noted, there are only about 11,000 cases of pediatric HIV infection in the U.S., as a result largely of prophylactic measures that reduce perinatal transmission, and the proportion is declining, compared with adult infections.

But in the rest of the world, 2.3 million children do not have access to HAART or, often, any therapy at all, they said. The central question, then, is “when they will receive (and, like their counterparts in the study by Gona et al, benefit from) the therapy that will allow them to reach adulthood.”

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Herpes rates growing, survey reveals

July 12, 2006

In what may be considered a touchy subject, a new study has confirmed an alarming number of Australian adults carry the genital herpes virus.

One in eight adults aged over 25 has the sexually transmitted infection, according to the latest edition of the Sexually Transmitted Infections journal. It also revealed that women were twice as likely as men to contract genital herpes.

Health expert Dr Darren Russell says 80 per cent of people with genital herpes don’t know they have it.

“That’s either because they don’t recognise it, or they’re not experiencing any symptoms,” he said.

“As a consequence, genital herpes infections can be passed on unknowingly. So one of the aims of the campaign is to increase awareness, and let people know about good tests available from GPs”

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Anti-herpes Drug Reduces Need For Caesarean Sections In Infected Women

July 11, 2006

Giving an anti-viral drug to pregnant women who have a history of genital herpes significantly lowers the rate of Caesarean sections needed to protect the infant from becoming infected with the virus, researchers at UT Southwestern Medical Center have found.

The UT Southwestern study is the first large-scale confirmation that the drug valacyclovir hydrochloride (Valtrex) is effective in the last month of pregnancy, the researchers said. The study appears in this month’s issue of the journal Obstetrics and Gynecology.

“I think this will help immensely in giving doctors stronger evidence in using this treatment,” said Dr. Jeanne Sheffield, assistant professor of obstetrics and gynecology at UT Southwestern and lead author of the study. “Besides reducing the number of herpes outbreaks at birth, we also dropped the numbers of women without symptoms who were shedding the virus into the birth canal.”

Herpes, one of the most common sexually transmitted viral infections, causes periods of genital sores, followed by months or years of dormancy. It can’t be cured, although the number and severity of outbreaks can be reduced through medication. Many women of reproductive age are unaware that they have the virus.

In rare cases, infants can catch herpes simplex virus from the birth canal or genital region of the mother during birth, even when the mother isn’t showing symptoms. Current medical protocol is to offer C-sections to all women with active genital herpes lesions at the time of delivery. Nonetheless, 70 percent of neonatal herpes cases occur in infants of women who asymptomatically shed the virus near delivery, according to the researchers.

“The whole goal of this study was to reduce active genital herpes lesions at delivery that require a Caesarean delivery to prevent neonatal herpes,” Dr. Sheffield said.

The UT Southwestern study, which involved 338 pregnant women with a history of genital herpes, was a randomized, double-blind trial, with neither the doctors nor the women knowing who was getting the medication.

Twenty-eight women had C-sections because of active herpes lesions. Seven of the 170 women in the valacyclovir group, or 4 percent, had the operation, while 21 of the 168 women in the placebo group, or 13 percent, had C-sections. The 69 percent reduction in the rate of clinical herpes simplex virus at the time of delivery was statistically significant, the researchers said.

None of the babies in either group were born with herpes. There also were no differences in complications between the valacyclovir and placebo groups.

“This work is a good example of a well-designed study that is of sufficient size to help clinicians and patients have confidence in the efficacy and safety of anti-viral suppression in late pregnancy,” said Dr. George Wendel, professor of obstetrics and gynecology and senior author of the study.

Other UT Southwestern researchers involved in the study were Dr. Vanessa Laibl, assistant professor of obstetrics and gynecology; Dr. Scott Roberts, associate professor of obstetrics and gynecology; and Dr. Pablo Sanchez, professor of pediatrics.

The work was supported in part by GlaxoSmithKline.

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Lipsovir Has Entered Phase III Clinical Study

July 7, 2006

The study will be conducted in the US and Canada and involves about 50 clinical centres. More than 2000 patients will be included in the study and 1270 will be treated. The study is expected to be completed during the autumn of 2007. The aim is to achieve FDA approval for market registration at the end of 2008. The study is designed to have prevention of ulcerative lesions as primary endpoint. Present medications have not been able to show such a beneficial effect in phase III studies and Lipsovir® could offer patients a unique treatment opportunity.

“It’s unique that a Swedish biotech company initiates phase III studies in their own regime. If we succeed in taking Lipsovir the whole way to registration it would be a milestone not just for Medivir but also for the whole sector,” comments Medivir’s CEO Lars Adlersson.

The market for treatments of labial herpes in the US was USD 383 m in 2005, of which 75% was prescription products with an underlying growth of 17%, 1) The market picture in Europe is more fragmented and the value is slightly less than half the US market.

Medivir will seek partner(s) for marketing and sales of Lipsovir® at a suitable time.

The Medivir group
Medivir develops pharmaceuticals for widely prevalent diseases with proteases as the target enzyme. The goal is to become a self-sustaining, profitable, research-based pharmaceutical company with proprietary products on the market. The company is located in Huddinge, Sweden and Chesterford Research Park, Essex, England.

The group comprises Medivir AB, subsidiary Medivir UK Ltd, Medivir HIV Franchise AB and Medivir Personal AB. At the end of December 2005, the group had 133 employees. In 1996 Medivir was listed on the O list at the Stockholm Stock Exchange (Stockholmsbörsen).

Medivir’s research portfolio embraces projects on hepatitis C, labial herpes, osteoporosis, rheumatoid arthritis (RA), asthma, multiple sclerosis (MS). Medivir has seven individual projects in development, of which one is entering phase III.

Medivir HIV Franchise AB is focused on the development and divestment of HIV/HBV projects and examining the clinical strategy for shingles drug MIV-606.

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UCT prof suspended over Aids tonic.

July 5, 2006

A University of Cape Town academic has been temporarily suspended from his research duties and his laboratory closed after an international journal associated him with a herbal tonic touted as an HIV/Aids treatment.

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“The University of Cape Town is aware of the report published in Nature Medicine. We regard the allegations in the report in a very serious light. However, (Professor Girish) Kotwal’s suspension will not affect any normal teaching activities,” said spokeswoman Skye Grove on Monday.

Allegations under investigation
She said allegations of possible professional misconduct in respect of Kotwal had been referred for investigation.

Grove confirmed that UCT had an “existing royalty agreement” with Secomet, the Stellenbosch-based manufacturers of the brew.

The royalties agreement means that UCT will receive money from the sale of the product, but the investigation will clarify this and Grove did not want to elaborate, saying more information would emerge as the inquiry proceeded.

“This (the agreement) will be reviewed after the completion of the preliminary investigation, which will determine whether or not disciplinary action will be taken,” said Grove.

The preliminary investigation is being chaired by one of the university’s vice-chancellors.

Kodwal linked to Aids tonic
Kotwal, principal investigator at the university’s medical biotechnology department, was named in the publication as having links to Secomet V -a tonic allegedly sold at health shops and traditional healers as Ithemba Lesizwe (Hope of the Nation).

On Monday afternoon, Kotwal, who had been out of the country, met with members of the university’s executive, including the dean of faculty of health sciences, Professor Marian Jacobs.

In a website article from the New York Academy of Sciences, Kotwal is named as the organiser of the First International Conference on Natural Products and Molecular Therapy, which drew some 150 scientists to South Africa, in January 2005.

The New York Academy of Sciences site said Kotwal and his team have been studying an extract from a plant of the Trifollium species Secomet-V (”V” for viral), which they have found stops HIV from entering and infecting new cells.

Appears to neutralise viruses
“Its precise mode of action is still unknown, but it appears to neutralise virus particles and render them non-infectious. In addition to testing the plant extract in the lab, Kotwal’s group gave it to a small number of people with AIDS whose CD4 cell counts had declined steeply,” according to the article.

It said the plant extract significantly reduced their viral loads within several months, and improved or reversed disease symptoms.

“Like ARVs, Secomet-V would not be a cure for AIDS, but a long-term treatment,” it said.

The article suggested that researchers found the plant extract was also a “broad-spectrum antiviral” that could be used against bird-flu.

“In lab tests, Secomet-V has been effective against poxviruses, HIV, herpes, SARS corona, and flu viruses, including the H5N2 bird flu strain rendering them all inactive.”

The article quotes Kotwal as saying this was exciting because there “is nothing else for Africa - no vaccine, no TAMIFLU. This research could be translated into a real impact on public health and preparedness against what people consider a pandemic flu.”

It said Kotwal wanted funding to test Secomet-V in larger groups of people in a multicentre clinical trial.

His team was seeking to identify the extract’s bioactive ingredient, and possibly produce a synthetic antiviral. – (Sapa)

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A head-to-toe guide to improving a woman’s health

July 3, 2006

From a woman’s hair to our toes, their bodies are different from those of the opposite sex. Research shows, for example, that women experience heart attacks differently than men. It also shows that certain tests may work better on women than men. Not only do they have different hormones, but they also have different needs and goals. They want to look good, with shiny hair, smooth skin and slender bodies. They want energy and health. And they want to feel good. To that end, consult the following manual for your body. It provides you with the latest
information you need on the right care, testing and understanding of your unique female body.

Hair
You can shine up even the most lackluster locks with the right treatment. Under a microscope, a smooth cuticle looks like a roof with all the shingles lying flat, but day-to-day styling, heat processing and coloring cause those shingles to lift. To get your hair to glimmer, do the following. Come clean. If you’re a styling-product junkie, you’ll need to banish the buildup, which is a guaranteed shine squelcher. Always use a heat-resistant product on your hair before drying.

Face
Cosmetic-counter makeup testers can host some potentially dangerous forms of bacteria that can irritate your skin. Germs on makeup testers aren’t a cause for public panic, but it is unhygienic and worth avoiding if you can. Testers and makeup counters were contaminated with a variety of germs, from the type of staph bacteria found on doorknobs to E. coli, fecal bacteria transmitted via contaminated hands. Contaminated makeup testers could lead to problems on the skin’s surface. You can pick up herpes from a tube of lipstick if a previous user had a cold sore, and conjunctivitis can be transferred via eye pencils or mascara.

Hands
For sunburned, chapped, or irritated skin, slather on 100 per cent pure aloe gel as often as necessary. Use gel straight from the plant (just slice off a piece of a leaf about an inch away from the tip and apply the gel) or buy it at health food stores.

Abdomen
If monthly abdominal cramps keep you from functioning at your best, consider drinking a glass of milk before taking your favorite over-the-counter painkiller. Premenopausal women need 1,000 mg of bone-protecting calcium daily (1,200 mg if you’re past menopause). Calcium supplements or three servings of low-fat dairy should do the trick.

Uterus
Loading up on produce instead of meat at the market may slash your risk of endometriosis-the painful migration of uterine lining into your abdomen and a major cause of infertility. Eating red meat daily and ham three times or more weekly upped risk by 80 per cent and 100 per cent respectively, compared with eating none.

Bones
It’s normal to shrink about an inch in later adulthood. But losing more height could be a sign of osteoporosis, the bone-thinning disease that can lead to deadly fractures. Women who had lost three or more inches were 10 times more likely to have the disease. Ask your doctor to start tracking your height yearly in your 40s, so you don’t miss a big clue.

Knees, feet and toes
New research suggests that high heels may have gotten a bum health rap. Twice as many women as men suffer from knee osteoarthritis, leading docs to speculate that high-heeled footwear explains this joint-pain gender gap. Another potential misconception is that gout strikes only wealthy old men with voracious eating and drinking habits. But you’re walking proof that even ordinary middle-aged women can develop this metabolic disorder.

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